Method for implanting a stimulator with a foil-like electrode portion

Inventors

Schobben, Daniel • Martens, Hubert • Schets, Marjolein • Pollet, Wim

Assignees

Salvia Bioelectronics BV

Abstract

In general, implantation of neurostimulation systems or device includes subcutaneous or percutaneous placement of at least the electrodes. Preferred are minimally invasive implantation procedures, systems and devices that can reliably operate for extended periods, and systems and devices providing a high degree of comfort for the subject. The implantation specialist may need to address adequate placement of the electrodes with respect to the nerve tissue to be stimulated, and to choose between one or more convenient locations for the elements of the system or device.Methods are provided comprising forming a first 1250 and second 1260 incision on opposite sides of a target location, and introducing a first introducer sheath 3050a under the skin with a maximum internal transverse cross-section less than the further maximum transverse cross-section 710 of an implantable stimulator. Such a method is advantageous if the maximum transverse cross-section 710 of the further portion is at least 1.2 times greater than the maximum transverse cross-section 730 of the first portion—the dimensions of the implantation tools may be reduced.A further method is provided wherein the first portion 630 with at least two electrodes 200, 400 is introduced in the skin layers between the nerve tissue 2003 to be stimulated and above or in the aponeurosis layer 2009. By being implanted deeper and/or more accurately, comfort and/or reliability for the subject may be improved. In addition, the chance that the stimulator is implanted under the nerve tissue is greatly increased.

Core Innovation

The implantable stimulator comprises a longitudinally-extended substrate with a conformable first portion and a further portion. The substrate includes a first surface and a second surface defining a thickness, and at least two electrodes are located along the conformable first portion. In some configurations the conformable first portion is foil-like, comprises two or more adjacent polymeric substrate layers, includes Liquid Crystal Polymer (LCP), and has a thickness equal to or less than 0.5 millimeters or equal to or less than 0.3 millimeters.

The implantation method identifies a target location for stimulation in transverse cross-section comprising an outer skin layer, nerve tissue to be stimulated, and an inner aponeurosis layer. One or more incisions are formed proximate the target location, and the conformable first portion is introduced into the skin layers such that the electrodes are disposed under the nerve tissue to be stimulated and above or in the inner aponeurosis layer, in some configurations directly adjacent to the aponeurosis layer and arranged between subcutaneous fat and the aponeurosis layer.

The method further positions the further portion in skin layers, including disposing the further portion below at least some subcutaneous fat, directly adjacent to and above or in muscle tissue, and between subcutaneous fat and a bone layer. The further portion may include a pulse energy receiver or pulse generator located along the further portion, and the routing includes introducing one or more introducer sheaths under the skin between incisions so that the stimulator extends under the skin from the further portion at one incision to a tip of the conformable portion at another incision.

The routing is compatible with a first maximum transverse cross-section and a further maximum transverse cross-section, with the further maximum transverse cross-section being at least 1.2 times the first maximum transverse cross-section. In some configurations electrical interconnection layers are positioned along a first polymeric substrate layer using a deposition technique and at least one second polymeric substrate layer covers the plurality of electrical interconnections.

Claims Coverage

The consolidated coverage includes three independent inventive features covering thin conformable electrode placement, under-skin introducer-sheath routing with transverse cross-section constraints, and foil-like layered construction with pulse generator or pulse energy receiver placement and headache treatment configuration.

The consolidated claim coverage centers on a thin conformable electrode portion placed relative to nerve tissue and the aponeurosis layer, a multi-incision introducer-sheath routing arrangement with cross-section constraints, and a layered foil-like construction with pulse energy receiver or pulse generator placement and headache treatment configuration.

Stated Advantages

Documented Applications